| Formulation of an intravenous emulsion loaded with a clarithromycin-phospholipid complex and its pharmacokinetics in rats. | |
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MedLine Citation:
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PMID: 18835427 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The purpose of this paper is to prepare a new formulation of clarithromycin emulsion (ClaE) with the clarithromycin-phospholipid complex which was analyzed by DSC. High-pressure homogenization, Nicomp 380 Particle Sizing system, and HPLC were used to prepare and investigate ClaE, while UPLC/MS/MS for pharmacokinetic study. Clarithromycin and soybean lecithin were reacted in dehydrated alcohol at a ratio of 1:10 for 3 h at 65 degrees C to prepare the complex. The ClaE formulation consisted of, according to quality percentage, the complex (clarithromycin 0.25% in ClaE), LCT 4%, MCT 16%, soybean lecithin 1.0%, F68 0.2%, Tween80 0.2%, glycerol 2.5%, sodium oleate 0.1% and L-cysteine 0.02%. ClaE was sterilized in a 100 degrees C revolving water bath for 30 min. The drug content, particle size distribution and entrapment efficiency of ClaE before and after sterilization and over 6 months storage at 10 degrees C were almost unchanged, while zeta-potential increased from -20.32 mV to -23.71 mV. These results show that ClaE has enough physicochemical stability to undergo sterilization and storage. The pharmacokinetic study showed that both ClaE and ClaS fitted a three-compartment model, their pharmacokinetic curves were similar and the main parameters showed no significant difference except Vss. ClaE has a great potential for clinical applications and industrial-scale production. |
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Authors:
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Yan Lu; Yu Zhang; Ziyi Yang; Xing Tang |
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Publication Detail:
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Type: Journal Article Date: 2008-09-16 |
Journal Detail:
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Title: International journal of pharmaceutics Volume: 366 ISSN: 0378-5173 ISO Abbreviation: Int J Pharm Publication Date: 2009 Jan |
Date Detail:
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Created Date: 2008-12-29 Completed Date: 2009-04-07 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7804127 Medline TA: Int J Pharm Country: Netherlands |
Other Details:
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Languages: eng Pagination: 160-9 Citation Subset: IM |
Affiliation:
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Department of Pharmaceutics, Shenyang Pharmaceutical University, Shenyang 110016, People's Republic of China. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Anti-Bacterial Agents / administration & dosage, pharmacokinetics* Chromatography, High Pressure Liquid Clarithromycin / administration & dosage, pharmacokinetics* Drug Stability Drug Storage Emulsions Excipients / chemistry* Lecithins / chemistry* Male Particle Size Rats Rats, Wistar Soybeans / chemistry Sterilization Tandem Mass Spectrometry |
| Chemical | |
Reg. No./Substance:
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0/Anti-Bacterial Agents; 0/Emulsions; 0/Excipients; 0/Lecithins; 81103-11-9/Clarithromycin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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